Local investors promote new prostate cancer treatment

Three South Florida investors are funding a company hoping to introduce a new prostate cancer treatment in the U.S.

The high-intensity focused ultrasound (HIFU) has treated more than 1,000 patients in foreign counties, including Mexico, Canada, India, parts of South America and the Bahamas. It is currently undergoing clinical trials in the U.S., where Charlotte, N.C.-based US HIFU hopes to prove that it is a viable alternative to robot-assisted prostate cancer surgery.

The company touts it as a way to treat prostate cancer with little risk of the two most common risks of the surgery – impotence and loss of bladder control. However, critics are quick to note that clinical data comparing the effectiveness of HIFU to surgery has not been produced.

In addition to impacting the lives of many men and their significant others, prostate surgery is big business. Annually, more than 90,000 men in the U.S. have their prostates removed due to cancer, according to the American Society of Clinical Oncology. US HIFU touts the procedure, which costs about $25,000, as cheaper than surgery.

“I wouldn’t do the old prostatectomy today, said Dr. George M. Suarez, a Miami urologist and co-founder of US HIFU. “Anything is better than impotence and being in a diaper.”

Positive experiences

Mike Kramer, the insurance trust administrator for the union representing Miami-Dade County firefighters, said a handful of members had a positive experience with HIFU, so the union’s self-funded insurance plan decided to cover the procedure for prostate cancer. It pays 80 percent of the cost up front.

Suarez saw HIFU on a trip to Spain, where the device was approved. In 2004, he and two partners founded US HIFU in Charlotte. The company later bought the Indianapolis-based manufacturer of the Sonablate.

The Sonablate machine, which looks like a computer with a wand, blasts high-frequency ultrasound waves at the liaisons on the prostate and superheats them. The patient then urinates out the dead tissue.

Suarez said the treatment does not hurt, and some patients who had it in Nassau, Bahamas, were soon up and about in the casino.

“These guys walk out of the hospital the same day,” said Dr. Bert Vorstman, a urologist in Coral Springs who is an investor in US HIFU and performs the treatment overseas. “The complication rates are minimal, at best.”

Miami attorney Alan Goldfarb is also an investor in US HIFU and has helped the company with its legal work. The shareholders have funded the company without turning to investment funds, Suarez said.

US HIFU has a Phase III clinical trial under way at 28 sites, including 16 academic centers, in the U.S. Suarez said he hopes to see results within the first nine months of 2012. Since he is an investor, Suarez is not allowed to host a clinical trial in his office. He treats patients with HIFU overseas.

Should the device obtain U.S. Food and Drug Administration approval, Suarez and Vorstman would seek to open training centers for physicians in South Florida, then nationwide.

Dr. Arnon Krongrad, a prostate cancer surgeon and CEO of Miami-based Mobile Surgical International, said there is no clinical data that shows the effectiveness of HIFU versus prostate surgery for treating cancer. Until there is such a completed study, patients receiving HIFU, even in countries where it is approved, should understand that the benefits are not proven, he said.

“If your objective is not to expose yourself to any risk of losing erections, there are many things you can do, including eating chicken soup,” Krongrad said. “But your objective here is not to die of cancer.”

Krongrad has read up on HIFU, but has not personally used the machine.

Suarez said many prostate surgeons have a bias against HIFU because they invested so much in robotic surgical equipment, which his machine could compete with.

US HIFU also plans to compete with the pharmaceutical industry. One of the clinical trials is for patients who failed radiation therapy and would otherwise by on female hormones, which account for billions of dollars in drug sales to men with such a condition.

“Female hormones for prostate cancer patients are like the chemical castration they give to sex offenders,” Vorstman said. “It has many negative side effects.”